NDA 211843

MISSION PHARMACAL CO

FDA Drug Application

Application #211843

Documents

• Letter: 2019-07-01
• Label: 2019-07-02
• Review: 2020-01-02
• Letter: 2021-03-09
• Label: 2021-03-10

Application Sponsors

NDA 211843

MISSION PHARMACAL CO

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, DELAYED RELEASE;ORAL	100MG	1	THIOLA EC	TIOPRONIN
002	TABLET, DELAYED RELEASE;ORAL	300MG	1	THIOLA EC	TIOPRONIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-06-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

MISSION PHARMACAL CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211843
            [companyName] => MISSION PHARMACAL CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"THIOLA EC","activeIngredients":"TIOPRONIN","strength":"100MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"THIOLA EC","activeIngredients":"TIOPRONIN","strength":"300MG","dosageForm":"TABLET, DELAYED RELEASE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/28\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211843s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/28\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211843s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211843Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211843Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-06-28
        )

)